Lanreotide Pregnancy and Breastfeeding Warnings

Brand names: Somatuline Depot

Lanreotide Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-This drug may reduce fertility in females of reproductive potential.

Animal studies showed decreased fetal growth and embryo/fetal survival, and increased skeletal/soft tissue abnormalities. Animal fertility was decreased, probably due to the suppression of growth hormone. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Lanreotide Breastfeeding Warnings

Subcutaneous lanreotide appeared in rat milk; animal data is not a reliable predictor of drug levels in human milk. An animal study during lactation showed growth retardation of the offspring prior to weaning, and reduced memory and learning test results in male offspring.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Use is contraindicated. (AU)

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Because of the potential for serious adverse effects, including on glucose metabolism and bradycardia, advise patients not to breastfeed during treatment and for 6 months (6 half-lives) after their last dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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